Chronic Periodontitis Clinical Trial
Official title:
Innovative Technology for Assessing the Periodontal Disease and New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin
The aim of the present study is to determine whether the association of Melatonin and Hyaluronic Acid to the antimicrobial TM paste (3% Tetracyclin and 3% Metronidazole) for periodontal maintenance therapy can improve the attachment level (AL) and alveolar bone support for moderate chronic periodontitis.
Local drug delivery agents in periodontology has gained acceptance and popularity compared to
systemic drugs due to decreased risk in development of resistant flora, opportunist
infection, and side effects.
In order to improve the topical treatment for chronic periodontitis, Melatonin and Hyaluronic
Acid have been added to antimicrobial topic paste commercially available.
- A complex matrix composed of Tetracycline, Metronidazole, Melatonin and Hyaluronic Acid
have been developed for local treatment of chronic periodontitis.
- Microbiological, physical, chemical characterization of the newly obtained matrix and
biocompatibility tests have been performed.
- A randomized clinical trial will be perform on 50 patients with moderate chronic
periodontitis recruited based on eligibility criteria and informed consent signed.
- Mechanical debridement of the pockets by scaling and root planning will be performed
prior to the adjunctive therapy.
- Extensive clinical examination including charting the remaining teeth, clinical
attachment level (CAL), presence of dental plaque (PI), gingival index (GI), calculus
(CI), bleeding on probing (BOP), radiographic assessment and identification of
periodontal pathogens with micro-IDent® test will be performed at the beginning of the
study and 6 month after its completion.
- Each patient will be randomized using sealed envelopes (according to a
computer-generated randomization list) to one of the following topical administration
(in the periodontal pocket of affected teeth), for 30 consecutive days: Tetracycline and
Metronidazole paste (TM), n=25 patients and Tetracycline, Metronidazole, Melatonin,
Hyaluronic Acid paste (TM-MHa), n=25 patients.
- A statistical evaluation of data recorded during the entire follow-up period will be
performed.
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